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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM
Generic NameVentricular (assist) bypass
ApplicantABIOMED CARDIOVASCULAR, INC.
22 CHERRY HILL DRIVE
DANVERS, MA 01923
PMA NumberP900023
Supplement NumberS038
Date Received01/27/2003
Decision Date09/24/2003
Withdrawal Date 02/01/2018
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE AB5000 BLOOD PUMP, USED ONLY WITH THE AB5000 CONSOLE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM AND IS INDICATED FOR USE IN PATIENTS SUFFERING FROM REVERSIBLE VENTRICULAR DYSFUNCTION. THESE ARE PATIENTS WHO HAVE UNDERGONE SUCCESSFUL CARDIAC SURGERY AND SUBSEQUENTLY DEVELOP LOW CARDIAC OUTPUT, OR PATIENTS WHO SUFFER FROM ACUTE CARDIAC DISORDERS LEADING TO HEMODYNAMIC INSTABILITY. THE INTENT OF AB5000 SYSTEM THERAPY IS TO PROVIDE CIRCULATORY SUPPORT, RESTORE NORMAL HEMODYNAMICS, REDUCE VENTRICULAR WORK, AND ALLOW THE HEART TIME TO RECOVER ADEQUATE MECHANICAL FUNCTION. THE AB5000 VENTRICLE IS EXTERNAL TO THE PATIENT AND IS INTENDED FOR SHORT-TERM USE. APPROPRIATE PATIENT GROUPS INCLUDE THOSE THAT ARE LIKELY TO RECOVER CARDIAC FUNCTION AFTER THE MYOCARDIUM IS PERMITTED TO REST ON VENTRICULAR SUPPORT. EXAMPLES INCLUDE, BUT ARE NOT LIMITED TO: 1) PATIENTS WHO FAIL TO WEAN FROM CARDIOPULMONARY BYPASS FOLLOWING HEART SURGERY. 2) FAILED TRANSPLANT PATIENTS WHO REQUIRE VENTRICULAR ASSIST FOLLOWING HEART TRANSPLANTATION. 3) PATIENTS WHO REQUIRE RIGHT HEART ASSIST (RVAD) SUPPORT WHILE ON IMPLANTABLE LEFT VENTRICULAR ASSIST DEVICE (LVAD). 4) PATIENTS SUFFERING FROM ACUTE CARDIAC DISORDERS SUCH AS VIRAL MYOCARDITIS. A PATIENT IS A CANDIDATE FOR MECHANICAL ASSISTANCE WITH THE AB5000 SYSTEM IF SHE/HE MEETS ALL OF THE FOLLOWING CRITERIA: A) PATIENT HAS A BODY SURFACE AREA > 1.3 M(SQUARED) AND IS <= 75 YEARS OF AGE. B) PATIENT IS IN RELATIVELY GOOD HEALTH OTHER THAN THE CARDIOVASCULAR PROBLEM FOR WHICH SURGERY WAS UNDERTAKEN. C) ALL APPROPRIATE MEASURES HAVE BEEN ATTEMPTED TO CORRECT LOW ARTERIAL PH, ARTERIAL BLOOD GAS ABNORMALITIES, ELECTROLYTES, HYPOVOLEMIA, HYPERVOLEMIA, INADEQUATE CARDIAC RATE, DYSRHYTHMIAS, AND RESIDUAL HYPOTHERMIA.D) CARDIAC RESUSCITATION EMPLOYING PHARMACOLOGIC AGENTS HAS BEEN ATTEMPTED. WHILE THE USE OF THE INTRA-AORTIC BALLOON PUMP (IABP) IS RECOMMENDED PRIOR TO...
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